FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DEVON SPONGE COUNTER BAGS
K Number: K912824
·
Decision Aug 26, 1991
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
14
Applicant Total
47
Review Days
61
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Basic Information
- Device Name
- DEVON SPONGE COUNTER BAGS
- K Number
- K912824
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.2740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Devon Industries, Inc.
- Date Received
- June 26, 1991
- Decision Date
- August 26, 1991
- Product Code
- LWH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LWH | Counter, Sponge, Surgical | FDA class 1 | General Hospital |
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Other Clearances by Devon Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961993 | BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) | Jul 3, 1996 | Substantially Equivalent |
| K954015 | ABG POINT LOK NEEDLE PROTECTION DEVICE | Nov 20, 1995 | Substantially Equivalent |
| K946289 | DEVONS POINT LOK NEEDLE PROTECTION DEVICE | Jul 10, 1995 | Substantially Equivalent |
| K945197 | THE SHARPS COLLECTION AND DISPOSAL SYSTEM | Dec 2, 1994 | Substantially Equivalent |
| K943892 | POINT OF USE SHARPS A GATOR | Dec 2, 1994 | Substantially Equivalent |
| K944114 | PHLEBOTOMY UNIT SHARPS A GATOR | Dec 2, 1994 | Substantially Equivalent |
| K945485 | ABG NEEDLE PROTECTION | Nov 29, 1994 | Substantially Equivalent |
| K932998 | EASY-ON | Aug 18, 1993 | Substantially Equivalent |
| K894170 | DEVON DISPOSABLE HEAD POSITIONER COVER | Sep 7, 1989 | Substantially Equivalent |
| K892660 | HIBERNATION KIT | Aug 15, 1989 | Substantially Equivalent |